Post Market Surveillance in the MDR Era - Building a Robust PMS System

This course provides a structured and practice oriented introduction to Post Market Surveillance (PMS) under the MDR. Participants learn how to design and operate a proactive PMS system that continuously monitors device performance and safety throughout the entire lifecycle. The training explains how PMS integrates with PMCF, clinical evaluation, risk management, and usability documentation. Real world examples illustrate how PMS data are collected, analyzed, and translated into meaningful actions that support regulatory compliance and ongoing product improvement.

Course Outline

• MDR PMS requirements and system obligations
• PMS and PMCF Plan structure and implementation
• Data sources, evaluation methods, and trend reporting
• PMS–PMCF–clinical evaluation interfaces
• PMS Reports and PSURs
• Updating technical documentation based on PMS findings
• Roles and responsibilities of manufacturers and economic operators
• Practical examples and solution oriented implementation strategies

Course Tutor

Alicia Knecht is a Senior Consultant in Medical Devices with extensive experience supporting manufacturers in achieving and maintaining compliance throughout the medical device lifecycle. She specializes in quality management systems, regulatory affairs, clinical evaluation, post-market surveillance, and risk management, helping organizations translate regulatory requirements into practical and sustainable processes. Alicia is recognized for her structured approach to gap analyses, remediation activities, and the development of compliant documentation in accordance with European and international regulatory requirements.

Her expertise includes the implementation and optimization of Quality Management Systems according to ISO 13485, as well as regulatory compliance under Regulation (EU) 2017/745. She has supported numerous projects involving technical documentation, CE marking, clinical evaluation, post-market surveillance, vigilance, complaint handling, and risk management.

Alicia also contributes to project management and training activities, supporting clients in establishing efficient processes and ensuring regulatory readiness. Her work is complemented by practical experience with medical device requirements, design documentation, and the integration of regulatory and quality processes throughout product development and post-market activities.

Alicia holds a Master of Science in Medical Engineering from Hamburg University of Technology.

Areas of Expertise: Quality Management Systems, Regulatory Affairs, Clinical Evaluation, Post-Market Surveillance, Risk Management, Technical Documentation, and Project Management.